Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff

Name: Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff
Creator: Food and Drug Administration
Keywords: 510k,arthroscopy,fda,guidances,industry,notification,patients,pre-market,pre-market-notification,submissions,tubing-sets

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Premarket

Published

December 23, 2021

Last updated

December 22, 2021

Description

This document is a guidance for industry and FDA staff on premarket notification submissions for arthroscopy pump tubing sets.

Organization

Food and Drug Administration (FDA) 🇺🇸

Country / Region

United States

License

Other (Public Domain)

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Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff

Updated on December 22, 2021

pdf (488.3KB)

URL: https://www.fda.gov/media/134667/download
Permalink: https://data.openrid.co/en/datasets/r/7a3b2ad4-d97c-4b96-a3dd-d4f7f087bc38
MIME Type: application/pdf

Created on: December 23, 2021
Modified on: December 22, 2021

Size: 488.3KB

Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff

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Regulated products

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Published

Last updated

Description

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